PACKAGE LEAFLET: INFORMATION FOR THE USER    C*****

Papaveretum Injection BP 15.4mg in 1ml

Papaveretum

Read all of this leaflet carefully before you are given this

medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, please ask your doctor or nurse.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

In this leaflet:

1.    What Papaveretum Injection is and what it is used for

2.    Before you are given Papaveretum Injection

3.    How Paravereum Injection will be given

4.    Possible side effects

5.    How to store Papaveretum Injection

6.    Further information

1. What Papaveretum Injection is and what it is used for

This medicine is a mixture of three active ingredients. Two of the active ingredients of this medicine; Morphine Hydrochloride and Codeine Hydrochloride, are powerful substances with pain relieving properties. The active ingredient Papaverine Hydrochloride is a muscle relaxant.

Papaveretum Injection is used for the relief of severe long-lasting or recurring pain. It may also be used to stop you from feeling pain before, during and after an operation.

2. Before you are given Papaveretum Injection

You should not be given Papaveretum Injection if you:

•    are allergic (hypersensitive) to Morphine Hydrochloride, Codeine Hydrochloride or Papaverine Hydrochloride, or to any of the ingredients listed in section 6 of this leaflet

•    are currently suffering from breathing difficulties or you usually suffer from breathing problems such as asthma

•    are currently having an asthma attack

•    are having stomach pains

•    have suffered a head injury or are experiencing severe and undiagnosed headaches

•    suffer from heart problems

•    suffer from a tumour of the adrenal gland known as phaeochromocytoma

•    are unable to open your bowels due to a blockage in your intestines (paralytic ileus)

•    are in a coma

•    suffer from alcoholism

•    have been told you are suffering from a condition known as delayed gastric emptying, the symptoms of which include heartburn, feeling sick or being sick and feeling full quickly whilst eating

•    suffer from a convulsive disorder (fits) such as epilepsy

Take special care with Papaveretum Injection

Tell your doctor if you:

•    are in labour

•    are elderly or ill

•    suffer from problems with your adrenal glands (adrenocortical insufficiency)

•    have low blood pressure

•    suffer from thyroid problems

•    suffer from problems with your prostate

•    have liver or kidney problems

•    are in shock, the symptoms of which include sweating, a fast pulse and cold, clammy skin

•    have an unusually fast heartbeat

•    are suffering from shortness of breath

•    have any lung problems, in particular emphysema (enlarged and damaged lungs)

•    are extremely overweight

•    suffer from spine problems

•    suffer from bowel problems

•    suffer from problems with your pancreas

•    suffer from a muscle disorder known as myasthenia gravis

•    are suffering from gall stones

If any of the above apply to you or your child please tell your

doctor.

Taking other medicines

Please tell your doctor or nurse if you are taking, or have recently taken, any other medicine including medicines obtained without prescription.

Papaveretum Injection must not be used with drugs used to treat severe depression, such as phenelzine or moclobemide, or if you are within 2 weeks of discontinuing them. These drugs are known as Monoamine Oxidase Inhibitors(MAOI's).

Other medicines which may interact with Papaveretum Injection include:

•    medicines used to reduce anxiety (anxiolytics)

•    medicines used to help you to sleep (hypnotics)

•    CNS depressants (drugs that act on the brain and make you feel drowsy or faint). These include sleeping pills, antihistamines (medicines used to treat allergies) that make you drowsy, medicines used to treat certain mental disorders, other pain killers or a general anaesthetic.

•    medicines used to treat mental disorders (antipsychotics)

•    ciprofloxacin, a medicine used to treat bacterial infections

If you are in any doubt please tell your doctor of any medication you are taking.

Pregnancy and breast-feeding:

Papaveretum Injection is thought to be safe to use if you are pregnant or breast-feeding, however you should still ask your doctor for advice before you are given this medicine.

Effects on the ability to drive and use machinery:

This medicine may cause drowsiness. If you are affected do not drive or use machines.

Having Papaveretum Injection with food and drink

You are advised not to drink alcohol during your treatment with this medicine.

Important information about some of the ingredients:

This medicine contains sodium metabisulphite and sodium sulphite which may cause allergic (hypersensitive) type reactions in some people and can lead to breathing difficulties or collapse. People with a history of asthma or allergies are most likely to experience these problems.

3. How Papaveretum Injection will be given

Your doctor will give Papaveretum Injection to you as an injection into a vein (intravenously), under the skin (subcutaneously) or into a muscle (intramuscularly). If you are receiving Papaveretum Injection for pain relief before or during an operation you will only be given the injection into a muscle or under the skin, not into a vein.

Your doctor will determine how much of Papaveretum Injection you need.

Adults:

The usual dose is a single dose of 7.7-15.4mg Elderly and infirm patients:

It is recommended that a reduced dose be used. The usual initial dose is up to a maximum of 7.7mg.

Children:

Under 1 month of age:

1 month to 1 year of age: 1 year to 5 years of age:

6 years to 12 years:

115 micrograms (0.115mg) per kilogram of bodyweight 154 micrograms (0.154mg) per kilogram of bodyweight 1.93-3.85mg as the maximum single dose

3.85-7.7mg as the maximum single dose

If you are given more Papaveretum Injection than you should be:

This medicine will be given to you in hospital so it is unlikely you will receive too much. Your doctor has information on how to recognise and treat an overdose.

If you feel unwell after being given this medicine, or are at all concerned you have been given too much, tell your doctor or nurse.

If you have any further questions on the use of this product, ask your doctor or nurse.

4. Possible Side Effects

Like all medicines Papaveretum Injection can cause side effects, although not everybody gets them.

Repeated use of papaveretum can result in tolerance and addiction

If any of the following symptoms occur tell your doctor or nurse immediately. These are symptoms of a serious allergic reaction.

•    sudden wheeziness and tightness of chest

•    swelling of eyelids, face or lips

•    skin lumps or hives

•    skin rash (red spots), itchiness, fever

•    collapse

Other side effects that may occur include:

•    hallucinations (seeing or hearing things that aren't real)

•    confusion

•    mood changes

•    feeling sad, restless or worried

•    headache

•    a feeling of spinning (vertigo)

•    dizziness

•    drowsiness

•    sweating

•    feeling faint on standing up from a seated position

•    pinpoint pupils

•    a faster or slower heartbeat than usual

•    facial flushing

•    slowed breathing or difficulty breathing

•    constipation

•    feeling or being sick

•    dry mouth

•    spasms in the lower abdomen

•    itching or a rash

•    reduced sex drive

•    difficulty achieving or maintaining an erection

•    difficulty passing urine

•    hypothermia, the symptoms of which include shivering, drowsiness and feeling weak

•    stomach pain

•    loss of appetite

•    indigestion

•    worsening of a condition that affects the pancreas known as pancreatitis. The symptoms of this include stomach pain and feeling or being sick.

•    changes in the way things taste

•    high blood pressure

•    tingling, pricking or numbness of the skin ('pins and needles')

•    seizures (fits)

•    fainting

•    feeling weak

•    a feeling of being unwell

•    feeling disoriented, confused or having problems concentrating

•    feeling excited

•    lack of menstruation (period)

•    twitching muscles

If any of these side effects get serious, or you notice any other side effects not listed in this leaflet, please tell your doctor or nurse.

5. How to Store Papaveretum Injection

Keep all medicines out of the reach and sight of children.

You should not be given Papaveretum Injection after the expiry date on the ampoule and carton label. The expiry date refers to the last day of that month. The doctor or nurse will check that the product has not passed this date.

Protect from light.

6. Further Information

What Papaveretum Injection contains Active ingredients: Papaveretum BP 15.4mg.

Other ingredients: Glycerol, Sodium Metabisulphite and Water for Injections. It may also contain Hydrochloric Acid.

What Papaveretum Injection looks like and contents of the pack:

The clear colourless solution is supplied in 1ml clear glass ampoules. Each pack contains 10 ampoules.

Marketing Authorisation Holder and Manufacturer:

Martindale Pharmaceuticals Ltd., Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom.

Product Licence Number:

PL 01883/6181R

This leaflet was last approved in: 09/2008

MARTINDALE

Pharmaceuticals

Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom